The Effect of Fetal Heartbeat Monitoring on Prenatal Attachment and Partner Adjustment

NCT06148415 | Completed

• 1 other identifier: KSUESRAKARATASOKYAY004
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this interventional study is to obtain information about determining the effect of the following drugs. To evaluate prenatal attachment levels and spousal adjustment in couples with fetal heart rate monitoring. The main questions it aims to answer are:

• Does fetal heart rate monitoring affect the attachment of pregnant women?
• Does fetal heart rate monitoring affect fathers' attachment?
• Does fetal heart rate monitoring affect pregnant women's adjustment to motherhood?

Conditions

Pregnancy Related

Keywords

Attachment; Fetal Heart Sound; Partner compatibility

Outcome Measures

Primary Outcomes (6)

• Assessment of prenatal maternal attachment level

  The scale has 19 items in total and each item focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5 (5= represents very strong feelings towards the fetus; 1= represents the absence of feelings towards the fetus). There are two sub-dimensions in the scale. The quality of attachment subscale refers to the quality of the pregnant woman's emotional experience of the fetus. The second sub-dimension, time spent on attachment, refers to the intensity of the time the pregnant woman spends thinking, talking and touching the fetus. A high score obtained from the scale indicates a high degree of attachment.

  The Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the first interview (day 1).

• Assessment of prenatal maternal attachment level

  The scale has 19 items in total and each item focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5 (5= represents very strong feelings towards the fetus; 1= represents the absence of feelings towards the fetus). There are two sub-dimensions in the scale. The quality of attachment subscale refers to the quality of the pregnant woman's emotional experience of the fetus. The second sub-dimension, time spent on attachment, refers to the intensity of the time the pregnant woman spends thinking, talking and touching the fetus. A high score obtained from the scale indicates a high degree of attachment.

  Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the last interview (day 15).

• Assessment of prenatal paternal attachment level

  The Prenatal Father Attachment Scale is based on measuring the father's feelings and thoughts towards the developing baby in the womb in line with the father's experiences in the last two weeks. There are 9 reverse items in the scale consisting of 16 items. Reverse items are scored by reversing them. The scale has 2 sub-dimensions: "quality of attachment (8 items)" and "time spent on attachment (8 items)". The items are scored between 1-5 and a minimum score of 16 and a maximum score of 80 is obtained from the scale. The higher the score obtained from the scale, the higher the prenatal attachment is considered to be.

  The Prenatal Father Attachment Scale will be administered to all expectant fathers in both groups at the first interview (day 1).

• Assessment of prenatal paternal attachment level

  The Prenatal Father Attachment Scale is based on measuring the father's feelings and thoughts towards the developing baby in the womb in line with the father's experiences in the last two weeks. There are 9 reverse items in the scale consisting of 16 items. Reverse items are scored by reversing them. The scale has 2 sub-dimensions: "quality of attachment (8 items)" and "time spent on attachment (8 items)". The items are scored between 1-5 and a minimum score of 16 and a maximum score of 80 is obtained from the scale. The higher the score obtained from the scale, the higher the prenatal attachment is considered to be.

  The Prenatal Father Attachment Scale will be administered to all prospective fathers in both groups in the last interview (day 15).

• Assessment of spousal adjustment of pregnant women

  This four-point Likert-type scale consists of 79 items. The scale has seven sub-dimensions: thoughts about her own and her baby's health, acceptance of pregnancy, acceptance of the maternal role, readiness for childbirth, fear of childbirth, relationship status with her own mother and relationship status with her partner. Each subscale contains between 10-15 items. Each item in the scale is evaluated on a four-point scale, and adaptation to pregnancy is scored from 1 to 4 (4: Very much defines, 3: Partially defines, 2: Somewhat defines, 1: Does not define at all). In this study, the relationship with spouse sub-dimension of the scale was used.

  Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups in the first interview (day 1).

• Assessment of spousal adjustment of pregnant women

  This four-point Likert-type scale consists of 79 items. The scale has seven sub-dimensions: thoughts about her own and her baby's health, acceptance of pregnancy, acceptance of the maternal role, readiness for childbirth, fear of childbirth, relationship status with her own mother and relationship status with her partner. Each subscale contains between 10-15 items. Each item in the scale is evaluated on a four-point scale, and adaptation to pregnancy is scored from 1 to 4 (4: Very much defines, 3: Partially defines, 2: Somewhat defines, 1: Does not define at all). In this study, the relationship with spouse sub-dimension of the scale was used.

  Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups at the last interview (day 15).

Study Arms (2)

Fetal Heartbeat Monitoring Group

EXPERIMENTAL

The prospective fathers will be trained by the investigators on how to perform the 1st and 2nd leopold maneuvers using visual materials. Each couple will be provided with a stethoscope to listen to the fetal heartbeat and will be given a schedule to listen to the fetal heartbeat together for 5-10 minutes at least once a day for 15 days. 1. Leopold maneuver (Posture): The first maneuver is performed to determine the height of the fundus and the part that is located on the fundus. 2. Leopold's maneuver (Position: back right, back left): This maneuver is used to determine which side the fetal back is on. On palpation, the side with the baby's back is flat and firmer, and the other side feels bumpy.

Behavioral: Fetal Heartbeat Monitoring Group

Control

NO INTERVENTION

Standard care group without fetal heart rate monitoring

Interventions

Fetal Heartbeat Monitoring Group BEHAVIORAL

Fetal Heartbeat Monitoring Group

Fetal Heartbeat Monitoring Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to communicate,
• Primigravida,
• Over 18 years of age,
• weeks of gestation and above and without any diagnosed risk (such as pre-eclampsia, diabetes, heart disease, placenta previa, oligohydramnios, multiple pregnancy) in the current pregnancy,
• Those who do not have any diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) will be included in the study.

You may not qualify if:

• Separated from his wife,
• In the first trimester of pregnancy,
• Those with any diagnosed risk in the mother or baby will not be included in the study.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

• Guney E, Ucar T. Effect of the fetal movement count on maternal-fetal attachment. Jpn J Nurs Sci. 2019 Jan;16(1):71-79. doi: 10.1111/jjns.12214. Epub 2018 May 17.

  PMID: 29774647 BACKGROUND

Related Links

• Description citation link

Study Officials

• Esra KARATAŞ OKYAY, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial conducted with experimental and control groups.

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 28, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)